UDI EUDAMED Attributes
- Multi-component devices are medical devices that are intended to be used in combination
- Medical devices that are not multi-component devices can either be a special device type devices or just a standard device
- Depending on the applicable legislation under which the medical device is authorized (MDR or IVDR) different types are possibble
Type of Multi-Component Device
- Product under MDR can be the following Type of Multi-Component Device:
- System: A combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose (e.g. syringe pumps and disposable syringes sold individually)
- Procedure Pack: A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose (e.g. blood pressure monitor marketed in a pack together with a suitable disinfectant)
- Product under IVDR can be the following Type of Multi-Component Device:
- Kit: A set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof (z.B. Covid test kit)
Special Device Type
- Product under MDR can be the following Special Device Type:
- Orthopaedic,
- Rigid Gas Permeable (RGP) & Made-to-Order Soft Contact Lenses
- Software
- Standard Soft Contact Lense
- Product under IVDR can be the following Special Device Type:
(Standard) Device
- If none of the above types of Type of Multi-Component Device and Special Device Type apply, it is a standard medical device
- Procuts under MDR:
- Procuts under IVDR:
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